System and method for noninvasive skin tightening

ABSTRACT

A method and system for noninvasive face lifts and deep tissue tightening are disclosed. An exemplary method and treatment system are configured for the imaging, monitoring, and thermal injury to treat the SMAS region. In accordance with an exemplary embodiment, the exemplary method and system are configured for treating the SMAS region by first, imaging of the region of interest for localization of the treatment area and surrounding structures, second, delivery of ultrasound energy at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect, and third to monitor the treatment area before, during, and after therapy to plan and assess the results and/or provide feedback.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of U.S. application Ser. No.15/958,939 filed on Apr. 20, 2018 and issued as U.S. Pat. No.10,525,288, which is a continuation of U.S. application Ser. No.15/098,139 filed on Apr. 13, 2016 and issued as U.S. Pat. No. 9,974,982,which is a continuation of U.S. application Ser. No. 13/964,820 filed onAug. 12, 2013 and issued as U.S. Pat. No. 9,320,537, which is acontinuation of U.S. application Ser. No. 12/028,636 filed on Feb. 8,2008 and issued as U.S. Pat. No. 8,535,228 on Sep. 17, 2013, which is acontinuation-in-part of U.S. application Ser. No. 11/163,151 filed onOct. 6, 2005, now abandoned, which in turn claims priority to U.S.Provisional Application No. 60/616,755 filed on Oct. 6, 2004, each ofwhich is incorporated by reference in its entirety. Further, U.S.application Ser. No. 12/028,636 is a continuation-in-part of U.S.application Ser. No. 11/163,148 filed on Oct. 6, 2005, now abandoned,which in turn claims priority to U.S. Provisional Application No.60/616,754 filed on Oct. 6, 2004, each of which is incorporated byreference in its entirety. Any and all priority claims identified in theApplication Data Sheet, or any correction thereto, are herebyincorporated by reference under 37 CFR 1.57.

BACKGROUND Field of the Invention

The present invention relates to ultrasound therapy and imaging systems,and in particular to a method and system for noninvasive face lifts anddeep tissue tightening.

Background of the Invention

Coarse sagging of the skin and facial musculature occurs gradually overtime due to gravity and chronic changes in connective tissue generallyassociated with aging. Invasive surgical treatment to tighten suchtissues is common, for example by facelift procedures. In thesetreatments for connective tissue sagging, a portion of the tissue isusually removed, and sutures or other fasteners are used to suspend thesagging tissue structures. On the face, the Superficial MuscularAponeurosis System (SMAS) forms a continuous layer superficial to themuscles of facial expression and beneath the skin and subcutaneous fat.Conventional face lift operations involve suspension of the SMAS throughsuch suture and fastener procedures.

No present procedures have been developed yet, which provide thecombination of targeted, precise, local heating to a specifiedtemperature region capable of inducing ablation (thermal injury) tounderlying skin and subcutaneous fat. Attempts have included the use ofradio frequency (RF) devices that have been used to produce heating andshrinkage of skin on the face with some limited success as anon-invasive alternative to surgical lifting procedures. However, RF isa dispersive form of energy deposition. RF energy is impossible tocontrol precisely within the heated tissue volume and depth, becauseresistive heating of tissues by RF energy occurs along the entire pathof electrical conduction through tissues. Another restriction of RFenergy for non-invasive tightening of the SMAS is unwanted destructionof the overlying fat and skin layers. The electric impedance to RFwithin fat, overlying the suspensory connective structures intended forshrinking, leads to higher temperatures in the fat than in the targetsuspensory structures. Similarly, mid-infrared lasers and other lightsources have been used to non-invasively heat and shrink connectivetissues of the dermis, again with limited success. However, light is notcapable of non-invasive treatment of SMAS because light does notpenetrate deeply enough to produce local heating there. Below a depth ofapproximately 1 mm, light energy is multiply scattered and cannot befocused to achieve precise local heating.

SUMMARY OF THE INVENTION

A method and system for noninvasive face lifts and deep tissuetightening are provided. An exemplary method and treatment system areconfigured for the imaging, monitoring, and thermal injury to treat theSMAS region. In accordance with an exemplary embodiment, the exemplarymethod and system are configured for treating the SMAS region by first,imaging of the region of interest for localization of the treatment areaand surrounding structures, second, delivery of ultrasound energy at adepth, distribution, timing, and energy level to achieve the desiredtherapeutic effect, and third to monitor the treatment area before,during, and after therapy to plan and assess the results and/or providefeedback.

In accordance with an exemplary embodiment, an exemplary treatmentsystem comprises an imaging/therapy probe, a control system and displaysystem. The imaging/therapy probe can comprise various probe and/ortransducer configurations. For example, the probe can be configured fora combined dual-mode imaging/therapy transducer, coupled or co-housedimaging/therapy transducers, or simply a therapy probe and an imagingprobe. The control system and display system can also comprise variousconfigurations for controlling probe and system functionality, includingfor example a microprocessor with software and a plurality ofinput/output devices, a system for controlling electronic and/ormechanical scanning and/or multiplexing of transducers, a system forpower delivery, systems for monitoring, systems for sensing the spatialposition of the probe and/or transducers, and systems for handling userinput and recording treatment results, among others.

In accordance with an exemplary embodiment, ultrasound imaging can beutilized for safety purposes, such as to avoid injuring vital structuressuch as the facial nerve (motor nerve), parotid gland, facial artery,and trigeminal nerve (for sensory functions) among others. For example,ultrasound imaging can be used to identify SMAS as the superficial layerwell defined by echoes overlying the facial muscles. Such muscles can bereadily seen and better identified by moving them, and their image maybe further enhanced via signal and image processing.

In accordance with an exemplary embodiment, ultrasound therapy viafocused ultrasound, an array of foci, a locus of foci, a line focus,and/or diffraction patterns from single element, multiple elements,annular array, one-, two-, or three-dimensional arrays, broadbandtransducers, and/or combinations thereof, with or without lenses,acoustic components, mechanical and/or electronic focusing are utilizedto treat the SMAS region at fixed and/or variable depth or dynamicallycontrollable depths and positions.

In accordance with another exemplary embodiment, a therapeutic treatmentmethod and system for controlled thermal injury of human superficialtissue is based on the ability to controllably create thermal lesions ofa variable shape, size, and depth through precise spatial and temporalcontrol of acoustic energy deposition. This system and method forcontrolled thermal injury can be used to complete various proceduressuch as face lifts and deep tissue tightening described herein. Inaccordance with an exemplary embodiment, an exemplary therapeutictreatment system includes a control system and a probe system that canfacilitate treatment planning, controlling and/or delivering of acousticenergy, and/or monitoring of treatment conditions to a region ofinterest. As a result, the ability to controllably produce conformallesions of thermal injury in superficial human tissue can be realized.

In accordance with another exemplary embodiment, a treatment method canenable the regions of thermal injury to comprise controlled conformalshapes and sizes and allow the tissue to be destroyed (ablated) in acontrolled spatial and temporal manner. For example, the thermal lesionsmay be suitably and selectively created with narrow or wide lateralextent, long or short axial length, and/or deep or shallow placement,including up to the tissue outer surface. Moreover, separate islands ofdestruction may also be created over part or whole of the tissueregion-of-interest, and/or contiguous or overlapping structures may beproduced out of discrete lesions.

In accordance with other exemplary embodiments of the present invention,exemplary methods can comprise scanning over part or whole of theregion-of-interest to produce contiguous thermal injury. The conformallesions can be achieved not only through the independent selection andcontrol of transducer acoustic energy spatial distribution, such asselection of transducer configuration and placement, but also throughtemporal control, such as through drive amplitude levels,frequency/waveform selection, and timing sequences that can be adjustedand optimized to control thermal ablation of tissue. In addition, thetemperature at the acoustic coupling interface can be controlled, thusfurther enabling another exemplary method of lesion formation control.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter of the invention is particularly pointed out in theconcluding portion of the specification. The invention, however, both asto organization and method of operation, may best be understood byreference to the following description taken in conjunction with theaccompanying drawing figures, in which like parts may be referred to bylike numerals:

FIG. 1 illustrates a block diagram of a treatment system in accordancewith an exemplary embodiment of the present invention;

FIGS. 2A-2F illustrates schematic diagrams of an ultrasoundimaging/therapy and monitoring system for treating the SMAS layer inaccordance with various exemplary embodiments of the present invention;

FIGS. 3A and 3B illustrate block diagrams of an exemplary control systemin accordance with exemplary embodiments of the present invention;

FIGS. 4A and 4B illustrate block diagrams of an exemplary probe systemin accordance with exemplary embodiments of the present invention;

FIG. 5 illustrates a cross-sectional diagram of an exemplary transducerin accordance with an exemplary embodiment of the present invention;

FIGS. 6A and 6B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with exemplary embodiments of the presentinvention;

FIG. 7 illustrates exemplary transducer configurations for ultrasoundtreatment in accordance with various exemplary embodiments of thepresent invention;

FIGS. 8A and 8B illustrate cross-sectional diagrams of an exemplarytransducer in accordance with another exemplary embodiment of thepresent invention;

FIG. 9 illustrates an exemplary transducer configured as atwo-dimensional array for ultrasound treatment in accordance with anexemplary embodiment of the present invention;

FIGS. 10A-10F illustrate cross-sectional diagrams of exemplarytransducers in accordance with other exemplary embodiments of thepresent invention;

FIG. 11 illustrates a schematic diagram of an acoustic coupling andcooling system in accordance with an exemplary embodiment of the presentinvention;

FIG. 12 illustrates a block diagram of a treatment system comprising anultrasound treatment subsystem combined with additional subsystems andmethods of treatment monitoring and/or treatment imaging as well as asecondary treatment subsystem in accordance with an exemplary embodimentof the present invention;

FIG. 13 illustrates a schematic diagram with imaging, therapy, ormonitoring being provided with one or more active or passive oralinserts in accordance with an exemplary embodiment of the presentinvention;

FIG. 14 illustrates a cross sectional diagram of a human superficialtissue region of interest including a plurality of lesions of controlledthermal injury in accordance with an exemplary embodiment of the presentinvention;

FIG. 15 illustrates an exemplary diagram of simulation results forvarious spatially controlled configurations in accordance with exemplaryembodiments of the present invention;

FIG. 16 illustrates an exemplary diagram of simulation results of a pairof lesioning and simulation results in accordance with the presentinvention; and

FIG. 17 illustrates another exemplary diagram of simulation results of apair of lesioning results in accordance with the present invention.

DETAILED DESCRIPTION

The present invention may be described herein in terms of variousfunctional components and processing steps. It should be appreciatedthat such components and steps may be realized by any number of hardwarecomponents configured to perform the specified functions. For example,the present invention may employ various medical treatment devices,visual imaging and display devices, input terminals and the like, whichmay carry out a variety of functions under the control of one or morecontrol systems or other control devices. In addition, the presentinvention may be practiced in any number of medical contexts and thatthe exemplary embodiments relating to a method and system fornoninvasive face lift and deep tissue tightening as described herein aremerely indicative of exemplary applications for the invention. Forexample, the principles, features and methods discussed may be appliedto any SMAS-like muscular fascia, such as platysma, temporal fascia,and/or occipital fascia, or any other medical application.

Further, various aspects of the present invention may be suitablyapplied to other applications. The system and method of the presentinvention may also be used for controlled thermal injury of varioustissue. Certain exemplary methods for controlled thermal injury tovarious tissues are disclosed in co-pending U.S. patent application Ser.No. 11/163,148 entitled “Method and System for Controlled Thermal Injuryof Human Superficial Tissue” filed on Oct. 5, 2005 to which priority isclaimed and which is incorporated herein by reference in its entirety aswell as the provisional application to which that application claimspriority to (U.S. Provisional Application No. 60/616,754 entitled“Method and System for Controlled Thermal Injury of Human SuperficialTissue”).

In accordance with various aspects of the present invention, a methodand system for noninvasive face lifts and deep tissue tightening areprovided. For example, in accordance with an exemplary embodiment, withreference to FIG. 1, an exemplary treatment system 100 configured totreat a region of interest 106 comprises a control system 102, animaging/therapy probe with acoustic coupling 104, and a display system108. Control system 102 and display system 108 can comprise variousconfigurations for controlling probe 102 and overall system 100functionality, such as, for example, a microprocessor with software anda plurality of input/output devices, system and devices for controllingelectronic and/or mechanical scanning and/or multiplexing oftransducers, a system for power delivery, systems for monitoring,systems for sensing the spatial position of the probe and/ortransducers, and/or systems for handling user input and recordingtreatment results, among others. Imaging/therapy probe 104 can comprisevarious probe and/or transducer configurations. For example, probe 104can be configured for a combined dual-mode imaging/therapy transducer,coupled or co-housed imaging/therapy transducers, or simply a separatetherapy probe and an imaging probe.

In accordance with an exemplary embodiment, treatment system 100 isconfigured for treating the SMAS region by first, imaging of region ofinterest 106 for localization of the treatment area and surroundingstructures, second, delivery of ultrasound energy at a depth,distribution, timing, and energy level to achieve the desiredtherapeutic effect, and third to monitor the treatment area before,during, and after therapy to plan and assess the results and/or providefeedback. According to another exemplary embodiment of the presentinvention, treatment system 100 is configured for controlled thermalinjury of human superficial tissue based on treatment system 100'sability to controllably create thermal lesions of conformally variableshape, size, and depth through precise spatial and temporal control ofacoustic energy deposition.

As to the treatment of the SMAS region, connective tissue can bepermanently tightened by thermal treatment to temperatures about 60degrees C. or higher. Upon ablating, collagen fibers shrink immediatelyby approximately 30% of their length. The shrunken fibers can producetightening of the tissue, wherein the shrinkage should occur along thedominant direction of the collagen fibers. Throughout the body, collagenfibers are laid down in connective tissues along the lines of chronicstress (tension). On the aged face, the collagen fibers of the SMASregion are predominantly oriented along the lines of gravitationaltension. Shrinkage of these fibers results in tightening of the SMAS inthe direction desired for correction of laxity and sagging due to aging.The treatment comprises the ablation of specific regions of the SMASregion and similar suspensory connective tissues.

In addition, the SMAS region varies in depth and thickness at differentlocations, e.g., between 0.5 mm to 5 mm or more. On the face, importantstructures such as nerves, parotid gland, arteries and veins are presentover, under or near the SMAS region. Tightening of the SMAS in certainlocations, such as the preauricular region associated with sagging ofthe cheek to create jowls, the frontal region to associated with saggingbrows, mandibular region associated with sagging neck, can be conducted.Treating through localized heating of regions of the SMAS or othersuspensory subcutaneous connective tissue structures to temperatures ofabout 60-90° C., without significant damage to overlying ordistal/underlying tissue, i.e., proximal tissue, as well as the precisedelivery of therapeutic energy to SMAS regions, and obtaining feedbackfrom the region of interest before, during, and after treatment can besuitably accomplished through treatment system 100.

To further illustrate an exemplary method and system 200, with referenceto FIG. 2, imaging of a region of interest 206, such as by imaging aregion 222 and displaying images 224 of the region of interest 206 on adisplay 208, to facilitate localization of the treatment area andsurrounding structures can initially be conducted. Next, delivery ofultrasound energy 220 at a suitably depth, distribution, timing, andenergy level to achieve the desired therapeutic effect of thermal injuryor ablation to treat SMAS region 216 can be suitably provided by probe204 through control by control system 202. Monitoring of the treatmentarea and surrounding structures before, during, and after therapy, i.e.,before, during, and after the delivery of ultrasound energy to SMASregion 216, can be provided to plan and assess the results and/orprovide feedback to control system 202 and a system user.

Ultrasound imaging and providing of images 224 can facilitate safetargeting of the SMAS layer 216. For example, with reference to FIG. 2B,specific targeting for the delivery of energy can be better facilitatedto avoid heating vital structures such as the facial nerve (motor nerve)234, parotid gland (which makes saliva) 236, facial artery 238, andtrigeminal nerve (for sensory functions) 232 among other regions.Further, use of imaging with targeted energy delivery to provide alimited and controlled depth of treatment can minimize the chance ofdamaging deep structures, such as for example, the facial nerve thatlies below the parotid, which is typically 10 mm thick.

In accordance with an exemplary embodiment, with reference to FIG. 2C,ultrasound imaging of region 222 of the region of interest 206 can alsobe used to delineate SMAS layer 216 as the superficial, echo-dense layeroverlying facial muscles 218. Such muscles can be seen via imagingregion 222 by moving muscles 218, for example by extensional flexing ofmuscle layer 218 generally towards directions 250 and 252. Such imagingof region 222 may be further enhanced via signal and image processing.Once SMAS layer 216 is localized and/or identified, SMAS layer 216 isready for treatment.

The delivery of ultrasound energy 220 at a suitably depth, distribution,timing, and energy level is provided by probe 204 through controlledoperation by control system 202 to achieve the desired therapeuticeffect of thermal injury to treat SMAS region 216. During operation,probe 204 can also be mechanically and/or electronically scanned withintissue surface region 226 to treat an extended area. In addition,spatial control of a treatment depth 220 can be suitably adjusted invarious ranges, such as between a wide range of approximately 0 to 15mm, suitably fixed to a few discrete depths, with an adjustment limitedto a fine range, e.g. approximately between 3 mm to 9 mm, and/ordynamically adjusted during treatment, to treat SMAS layer 216 thattypically lies at a depth between approximately 5 mm to 7 mm. Before,during, and after the delivery of ultrasound energy to SMAS region 216,monitoring of the treatment area and surrounding structures can beprovided to plan and assess the results and/or provide feedback tocontrol system 202 and a system user.

For example, in accordance with an exemplary embodiment, with additionalreference to FIG. 2D, ultrasound imaging of region 222 can be used tomonitor treatment by watching the amount of shrinkage of SMAS layer 216in direction of areas 260 and 262, such as in real time or quasi-realtime, during and after energy delivery to region 220. The onset ofsubstantially immediate shrinkage of SMAS layer 216 is detectable byultrasound imaging of region 222 and may be further enhanced via imageand signal processing. The monitoring of such shrinkage can be idealbecause it can confirm the intended therapeutic goal of noninvasivelifting and tissue tightening; in addition, such monitoring may be usedfor system feedback. In addition to image monitoring, additionaltreatment parameters that can be suitably monitored in accordance withvarious other exemplary embodiments may include temperature, video,profilometry, strain imaging and/or gauges or any other suitablespatial, temporal and/or other tissue parameters.

For example, in accordance with an exemplary embodiment of the presentinvention, with additional reference to FIG. 2E, an exemplary monitoringmethod and system 200 may suitably monitor the temperature profile orother tissue parameters of the region of interest 206, such asattenuation or speed of sound of treatment region 222 and suitablyadjust the spatial and/or temporal characteristics and energy levels ofultrasound therapy transducer probe 204. The results of such monitoringtechniques may be indicated on display 208 in various manners, such as,for example, by way of one-, two-, or three-dimensional images ofmonitoring results 270, or may comprise an indicator 272, such as asuccess, fail and/or completed/done type of indication, or combinationsthereof.

In accordance with another exemplary embodiment, with reference to FIG.2F, the targeting of particular region 220 within SMAS layer 216 can besuitably be expanded within region of interest 206 to include acombination of tissues, such as skin 210, dermis 212, fat/adipose tissue214, SMAS/muscular fascia/and/or other suspensory tissue 216, and muscle218. Treatment of a combination of such tissues and/or fascia may betreated including at least one of SMAS layer 216 or other layers ofmuscular fascia in combination with at least one of muscle tissue,adipose tissue, SMAS and/or other muscular fascia, skin, and dermis, canbe suitably achieved by treatment system 200. For example, treatment ofSMAS layer 216 may be performed in combination with treatment of dermis280 by suitable adjustment of the spatial and temporal parameters ofprobe 204 within treatment system 200.

In accordance with various aspects of the present invention, atherapeutic treatment method and system for controlled thermal injury ofhuman superficial tissue to effectuate face lifts, deep tissuetightening, and other procedures is based on the ability to controllablycreate thermal lesions of conformally variable shape, size, and depththrough precise spatial and temporal control of acoustic energydeposition. With reference to FIG. 1, in accordance with an exemplaryembodiment, an exemplary therapeutic treatment system 200 includes acontrol system 102 and a probe system 104 that can facilitate treatmentplanning, controlling and/or delivering of acoustic energy, and/ormonitoring of treatment conditions to a region of interest 106.Region-of-interest 106 is configured within the human superficial tissuecomprising from just below the tissue outer surface to approximately 30mm or more in depth.

Therapeutic treatment system 100 is configured with the ability tocontrollably produce conformal lesions of thermal injury in superficialhuman tissue within region of interest 106 through precise spatial andtemporal control of acoustic energy deposition, i.e., control of probe104 is confined within selected time and space parameters, with suchcontrol being independent of the tissue. In accordance with an exemplaryembodiment, control system 102 and probe system 104 can be suitablyconfigured for spatial control of the acoustic energy by controlling themanner of distribution of the acoustical energy. For example, spatialcontrol may be realized through selection of the type of one or moretransducer configurations insonifying region of interest 106, selectionof the placement and location of probe system 104 for delivery ofacoustical energy relative to region-of-interest 106, e.g., probe system104 being configured for scanning over part or whole ofregion-of-interest 106 to produce contiguous thermal injury having aparticular orientation or otherwise change in distance fromregion-of-interest 106, and/or control of other environment parameters,e.g., the temperature at the acoustic coupling interface can becontrolled, and/or the coupling of probe 104 to human tissue. Inaddition to the spatial control parameters, control system 102 and probesystem 104 can also be configured for temporal control, such as throughadjustment and optimization of drive amplitude levels,frequency/waveform selections, e.g., the types of pulses, bursts orcontinuous waveforms, and timing sequences and other energy drivecharacteristics to control thermal ablation of tissue. The spatialand/or temporal control can also be facilitated through open-loop andclosed-loop feedback arrangements, such as through the monitoring ofvarious spatial and temporal characteristics. As a result, control ofacoustical energy within six degrees of freedom, e.g., spatially withinthe X, Y and Z domain, as well as the axis of rotation within the XY, YZand XZ domains, can be suitably achieved to generate conformal lesionsof variable shape, size and orientation.

For example, through such spatial and/or temporal control, an exemplarytreatment system 100 can enable the regions of thermal injury to possessarbitrary shape and size and allow the tissue to be destroyed (ablated)in a controlled manner. With reference to FIG. 14, one or more thermallesions may be created within a tissue region of interest 1400, withsuch thermal lesions having a narrow or wide lateral extent, long orshort axial length, and/or deep or shallow placement, including up to atissue outer surface 1403. For example, cigar shaped lesions may beproduced in a vertical disposition 1404 and/or horizontal disposition1406. In addition, raindrop-shaped lesions 1408, flat planar lesions1410, round lesions 1412 and/or other v-shaped/ellipsoidal lesions 1414may be formed, among others. For example, mushroom-shaped lesion 1420may be provided, such as through initial generation of an initial roundor cigar-shaped lesion 1422, with continued application of ablativeultrasound resulting in thermal expansion to further generate a growinglesion 1424, such thermal expansion being continued untilraindrop-shaped lesion 1420 is achieved. The plurality of shapes canalso be configured in various sizes and orientations, e.g., lesions 1408could be rotationally oriented clockwise or counterclockwise at anydesired angle, or made larger or smaller as selected, all depending onspatial and/or temporal control. Moreover, separate islands ofdestruction, i.e., multiple lesions separated throughout the tissueregion, may also be created over part of or the whole portion withintissue region-of-interest 1400. In addition, contiguous structuresand/or overlapping structures 1416 may be provided from the controlledconfiguration of discrete lesions. For example, a series of one or morecrossed-lesions 1418 can be generated along a tissue region tofacilitate various types of treatment methods.

The specific configurations of controlled thermal injury are selected toachieve the desired tissue and therapeutic effect(s). For example, anytissue effect can be realized, including but not limited to thermal andnon-thermal streaming, cavitational, hydrodynamic, ablative, hemostatic,diathermic, and/or resonance-induced tissue effects. Such effects can besuitably realized at treatment depths over a range of approximately0-30000 μm within region of interest 200 to provide a high degree ofutility.

An exemplary control system 202 and display system 208 may be configuredin various manners for controlling probe and system functionality. Withreference again to FIGS. 3A and 3B, in accordance with exemplaryembodiments, an exemplary control system 300 can be configured forcoordination and control of the entire therapeutic treatment process fornoninvasive face lifts and deep tissue tightening. For example, controlsystem 300 can suitably comprise power source components 302, sensingand monitoring components 304, cooling and coupling controls 306, and/orprocessing and control logic components 308. Control system 300 can beconfigured and optimized in a variety of ways with more or lesssubsystems and components to implement the therapeutic system forcontrolled thermal injury, and the embodiments in FIGS. 3A and 3B aremerely for illustration purposes.

For example, for power sourcing components 302, control system 300 cancomprise one or more direct current (DC) power supplies 303 configuredto provide electrical energy for entire control system 300, includingpower required by a transducer electronic amplifier/driver 312. A DCcurrent sense device 305 can also be provided to confirm the level ofpower going into amplifiers/drivers 312 for safety and monitoringpurposes.

Amplifiers/drivers 312 can comprise multi-channel or single channelpower amplifiers and/or drivers. In accordance with an exemplaryembodiment for transducer array configurations, amplifiers/drivers 312can also be configured with a beamformer to facilitate array focusing.An exemplary beamformer can be electrically excited by anoscillator/digitally controlled waveform synthesizer 310 with relatedswitching logic.

The power sourcing components can also include various filteringconfigurations 314. For example, switchable harmonic filters and/ormatching may be used at the output of amplifier/driver 312 to increasethe drive efficiency and effectiveness. Power detection components 316may also be included to confirm appropriate operation and calibration.For example, electric power and other energy detection components 316may be used to monitor the amount of power going to an exemplary probesystem.

Various sensing and monitoring components 304 may also be suitablyimplemented within control system 300. For example, in accordance withan exemplary embodiment, monitoring, sensing and interface controlcomponents 324 may be configured to operate with various motiondetection systems implemented within transducer probe 204 to receive andprocess information such as acoustic or other spatial and temporalinformation from a region of interest. Sensing and monitoring componentscan also include various controls, interfacing and switches 309 and/orpower detectors 316. Such sensing and monitoring components 304 canfacilitate open-loop and/or closed-loop feedback systems withintreatment system 200.

Still further, monitoring, sensing and interface control components 324may comprise imaging systems configured for one-dimensional,two-dimensional and/or three dimensional imaging functions. Such imagingsystems can comprise any imaging modality based on at least one ofphotography and other visual optical methods, magnetic resonance imaging(MRI), computed tomography (CT), optical coherence tomography (OCT),electromagnetic, microwave, or radio frequency (RF) methods, positronemission tomography (PET), infrared, ultrasound, acoustic, or any othersuitable method of visualization, localization, or monitoring of aregion-of-interest 106. Still further, various other tissue parametermonitoring components, such as temperature measuring devices andcomponents, can be configured within monitoring, sensing and interfacecontrol components 324, such monitoring devices comprising any modalitynow known or hereinafter devised.

Cooling/coupling control systems 306 may be provided to remove wasteheat from an exemplary probe 204, provide a controlled temperature atthe superficial tissue interface and deeper into tissue, and/or provideacoustic coupling from transducer probe 204 to region-of-interest 206.Such cooling/coupling control systems 306 can also be configured tooperate in both open-loop and/or closed-loop feedback arrangements withvarious coupling and feedback components.

Processing and control logic components 308 can comprise various systemprocessors and digital control logic 307, such as one or more ofmicrocontrollers, microprocessors, field-programmable gate arrays(FPGAs), computer boards, and associated components, including firmwareand control software 326, which interfaces to user controls andinterfacing circuits as well as input/output circuits and systems forcommunications, displays, interfacing, storage, documentation, and otheruseful functions. System software and firmware 326 controls allinitialization, timing, level setting, monitoring, safety monitoring,and all other system functions required to accomplish user-definedtreatment objectives. Further, various control switches 308 can also besuitably configured to control operation.

An exemplary transducer probe 204 can also be configured in variousmanners and comprise a number of reusable and/or disposable componentsand parts in various embodiments to facilitate its operation. Forexample, transducer probe 204 can be configured within any type oftransducer probe housing or arrangement for facilitating the coupling oftransducer to a tissue interface, with such housing comprising variousshapes, contours and configurations. Transducer probe 204 can compriseany type of matching, such as for example, electric matching, which maybe electrically switchable; multiplexer circuits and/or aperture/elementselection circuits; and/or probe identification devices, to certifyprobe handle, electric matching, transducer usage history andcalibration, such as one or more serial EEPROM (memories). Transducerprobe 204 may also comprise cables and connectors; motion mechanisms,motion sensors and encoders; thermal monitoring sensors; and/or usercontrol and status related switches, and indicators such as LEDs. Forexample, a motion mechanism in probe 204 may be used to controllablycreate multiple lesions, or sensing of probe motion itself may be usedto controllably create multiple lesions and/or stop creation of lesions,e.g. for safety reasons if probe 204 is suddenly jerked or is dropped.In addition, an external motion encoder arm may be used to hold theprobe during use, whereby the spatial position and attitude of probe 104is sent to the control system to help controllably create lesions.Furthermore, other sensing functionality such as profilometers or otherimaging modalities may be integrated into the probe in accordance withvarious exemplary embodiments. Moreover, the therapy contemplated hereincan also be produced, for example, by transducers disclosed in U.S.application Ser. No. 10/944,499, filed on Sep. 16, 2004, entitled METHODAND SYSTEM FOR ULTRASOUND TREATMENT WITH A MULTI-DIRECTIONAL TRANSDUCERand U.S. application Ser. No. 10/944,500, filed on Sep. 16, 2004, andentitled SYSTEM AND METHOD FOR VARIABLE DEPTH ULTRASOUND TREATMENT, bothhereby incorporated by reference.

With reference to FIGS. 4A and 4B, in accordance with an exemplaryembodiment, a transducer probe 400 can comprise a control interface 402,a transducer 404, coupling components 406, and monitoring/sensingcomponents 408, and/or motion mechanism 410. However, transducer probe400 can be configured and optimized in a variety of ways with more orless parts and components to provide ultrasound energy for controlledthermal injury, and the embodiment in FIGS. 4A and 4B are merely forillustration purposes. Transducer 404 can be any transducer configuredto produce conformal lesions of thermal injury in superficial humantissue within a region of interest through precise spatial and temporalcontrol of acoustic energy deposition.

Control interface 402 is configured for interfacing with control system300 to facilitate control of transducer probe 400. Control interfacecomponents 402 can comprise multiplexer/aperture select 424, switchableelectric matching networks 426, serial EEPROMs and/or other processingcomponents and matching and probe usage information 430 and interfaceconnectors 432.

Coupling components 406 can comprise various devices to facilitatecoupling of transducer probe 400 to a region of interest. For example,coupling components 406 can comprise cooling and acoustic couplingsystem 420 configured for acoustic coupling of ultrasound energy andsignals. Acoustic cooling/coupling system 420 with possible connectionssuch as manifolds may be utilized to couple sound into theregion-of-interest, control temperature at the interface and deeper intotissue, provide liquid-filled lens focusing, and/or to remove transducerwaste heat. Coupling system 420 may facilitate such coupling through useof various coupling mediums, including air and other gases, water andother fluids, gels, solids, and/or any combination thereof, or any othermedium that allows for signals to be transmitted between transduceractive elements 412 and a region of interest. In addition to providing acoupling function, in accordance with an exemplary embodiment, couplingsystem 420 can also be configured for providing temperature controlduring the treatment application. For example, coupling system 420 canbe configured for controlled cooling of an interface surface or regionbetween transducer probe 400 and a region of interest and beyond bysuitably controlling the temperature of the coupling medium. Thesuitable temperature for such coupling medium can be achieved in variousmanners, and utilize various feedback systems, such as thermocouples,thermistors or any other device or system configured for temperaturemeasurement of a coupling medium. Such controlled cooling can beconfigured to further facilitate spatial and/or thermal energy controlof transducer probe 400.

In accordance with an exemplary embodiment, with additional reference toFIG. 11, acoustic coupling and cooling 1140 can be provided toacoustically couple energy and imaging signals from transducer probe1104 to and from the region of interest 1106, to provide thermal controlat the probe to region-of-interest interface 1110 and deeper intotissue, and to remove potential waste heat from the transducer probe atregion 1144. Temperature monitoring can be provided at the couplinginterface via a thermal sensor 1146 to provides a mechanism oftemperature measurement 1148 and control via control system 1102 and athermal control system 1142. Thermal control may consist of passivecooling such as via heat sinks or natural conduction and convection orvia active cooling such as with peltier thermoelectric coolers,refrigerants, or fluid-based systems comprised of pump, fluid reservoir,bubble detection, flow sensor, flow channels/tubing 1144 and thermalcontrol 1142.

With continued reference to FIG. 4, monitoring and sensing components408 can comprise various motion and/or position sensors 416, temperaturemonitoring sensors 418, user control and feedback switches 414 and otherlike components for facilitating control by control system 300, e.g., tofacilitate spatial and/or temporal control through open-loop andclosed-loop feedback arrangements that monitor various spatial andtemporal characteristics.

Motion mechanism 410 can comprise manual operation, mechanicalarrangements, or some combination thereof. For example, a motionmechanism 422 can be suitably controlled by control system 300, such asthrough the use of accelerometers, encoders or otherposition/orientation devices 416 to determine and enable movement andpositions of transducer probe 400. Linear, rotational or variablemovement can be facilitated, e.g., those depending on the treatmentapplication and tissue contour surface.

Transducer 404 can comprise one or more transducers configured fortreating of SMAS layers and targeted regions. Transducer 404 can alsocomprise one or more transduction elements and/or lenses 412. Thetransduction elements can comprise a piezoelectrically active material,such as lead zirconante titanate (PZT), or any other piezoelectricallyactive material, such as a piezoelectric ceramic, crystal, plastic,and/or composite materials, as well as lithium niobate, lead titanate,barium titanate, and/or lead metaniobate. In addition to, or instead of,a piezoelectrically active material, transducer 404 can comprise anyother materials configured for generating radiation and/or acousticalenergy. Transducer 404 can also comprise one or more matching layersconfigured along with the transduction element such as coupled to thepiezoelectrically active material. Acoustic matching layers and/ordamping may be employed as necessary to achieve the desiredelectroacoustic response.

In accordance with an exemplary embodiment, the thickness of thetransduction element of transducer 404 can be configured to be uniform.That is, a transduction element 412 can be configured to have athickness that is substantially the same throughout. In accordance withanother exemplary embodiment, the thickness of a transduction element412 can also be configured to be variable. For example, transductionelement(s) 412 of transducer 404 can be configured to have a firstthickness selected to provide a center operating frequency ofapproximately 2 kHz to 75 MHz, such as for imaging applications.Transduction element 412 can also be configured with a second thicknessselected to provide a center operating frequency of approximately 2 to400 MHz, and typically between 4 MHz and 15 MHz for therapy application.Transducer 404 can be configured as a single broadband transducerexcited with at least two or more frequencies to provide an adequateoutput for generating a desired response. Transducer 404 can also beconfigured as two or more individual transducers, wherein eachtransducer comprises one or more transduction element. The thickness ofthe transduction elements can be configured to provide center-operatingfrequencies in a desired treatment range. For example, transducer 404can comprise a first transducer configured with a first transductionelement having a thickness corresponding to a center frequency range ofapproximately 1 kHz to 3 MHz, and a second transducer configured with asecond transduction element having a thickness corresponding to a centerfrequency of approximately 3 MHz to 100 MHz or more.

Transducer 404 may be composed of one or more individual transducers inany combination of focused, planar, or unfocused single-element,multi-element, or array transducers, including 1-D, 2-D, and annulararrays; linear, curvilinear, sector, or spherical arrays; spherically,cylindrically, and/or electronically focused, defocused, and/or lensedsources. For example, with reference to an exemplary embodiment depictedin FIG. 5, transducer 500 can be configured as an acoustic array tofacilitate phase focusing. That is, transducer 500 can be configured asan array of electronic apertures that may be operated by a variety ofphases via variable electronic time delays. By the term “operated,” theelectronic apertures of transducer 500 may be manipulated, driven, used,and/or configured to produce and/or deliver an energy beam correspondingto the phase variation caused by the electronic time delay. For example,these phase variations can be used to deliver defocused beams, planarbeams, and/or focused beams, each of which may be used in combination toachieve different physiological effects in a region of interest 510.Transducer 500 may additionally comprise any software and/or otherhardware for generating, producing and or driving a phased aperturearray with one or more electronic time delays.

Transducer 500 can also be configured to provide focused treatment toone or more regions of interest using various frequencies. In order toprovide focused treatment, transducer 500 can be configured with one ormore variable depth devices to facilitate treatment. For example,transducer 500 may be configured with variable depth devices disclosedin U.S. patent application Ser. No. 10/944,500, entitled “System andMethod for Variable Depth Ultrasound”, filed on Sep. 16, 2004, having atleast one common inventor and a common Assignee as the presentapplication, and incorporated herein by reference. In addition,transducer 500 can also be configured to treat one or more additionalROI 510 through the enabling of sub-harmonics or pulse-echo imaging, asdisclosed in U.S. patent application Ser. No. 10/944,499, entitled“Method and System for Ultrasound Treatment with a Multi-directionalTransducer”, filed on Sep. 16, 2004, having at least one common inventorand a common Assignee as the present application, and also incorporatedherein by reference.

Moreover, any variety of mechanical lenses or variable focus lenses,e.g. liquid-filled lenses, may also be used to focus and or defocus thesound field. For example, with reference to exemplary embodimentsdepicted in FIGS. 6A and 6B, transducer 600 may also be configured withan electronic focusing array 604 in combination with one or moretransduction elements 606 to facilitate increased flexibility intreating ROI 610. Array 604 may be configured in a manner similar totransducer 502. That is, array 604 can be configured as an array ofelectronic apertures that may be operated by a variety of phases viavariable electronic time delays, for example, T1, T2 . . . Tj. By theterm “operated,” the electronic apertures of array 604 may bemanipulated, driven, used, and/or configured to produce and/or deliverenergy in a manner corresponding to the phase variation caused by theelectronic time delay. For example, these phase variations can be usedto deliver defocused beams, planar beams, and/or focused beams, each ofwhich may be used in combination to achieve different physiologicaleffects in ROI 610.

Transduction elements 606 may be configured to be concave, convex,and/or planar. For example, in an exemplary embodiment depicted in FIG.6A, transduction elements 606A are configured to be concave in order toprovide focused energy for treatment of ROI 610. Additional embodimentsare disclosed in U.S. patent application Ser. No. 10/944,500, entitled“Variable Depth Transducer System and Method”, and again incorporatedherein by reference.

In another exemplary embodiment, depicted in FIG. 6B, transductionelements 606B can be configured to be substantially flat in order toprovide substantially uniform energy to ROI 610. While FIGS. 6A and 6Bdepict exemplary embodiments with transduction elements 604 configuredas concave and substantially flat, respectively, transduction elements604 can be configured to be concave, convex, and/or substantially flat.In addition, transduction elements 604 can be configured to be anycombination of concave, convex, and/or substantially flat structures.For example, a first transduction element can be configured to beconcave, while a second transduction element can be configured to besubstantially flat.

With reference to FIGS. 8A and 8B, transducer 404 can be configured assingle-element arrays, wherein a single-element 802, e.g., atransduction element of various structures and materials, can beconfigured with a plurality of masks 804, such masks comprising ceramic,metal or any other material or structure for masking or altering energydistribution from element 802, creating an array of energy distributions808. Masks 804 can be coupled directly to element 802 or separated by astandoff 806, such as any suitably solid or liquid material.

An exemplary transducer 404 can also be configured as an annular arrayto provide planar, focused and/or defocused acoustical energy. Forexample, with reference to FIGS. 10A and 10B, in accordance with anexemplary embodiment, an annular array 1000 can comprise a plurality ofrings 1012, 1014, 1016 to N. Rings 1012, 1014, 1016 to N can bemechanically and electrically isolated into a set of individualelements, and can create planar, focused, or defocused waves. Forexample, such waves can be centered on-axis, such as by methods ofadjusting corresponding transmit and/or receive delays, T1, T2, T3 . . .TN. An electronic focus can be suitably moved along various depthpositions, and can enable variable strength or beam tightness, while anelectronic defocus can have varying amounts of defocusing. In accordancewith an exemplary embodiment, a lens and/or convex or concave shapedannular array 1000 can also be provided to aid focusing or defocusingsuch that any time differential delays can be reduced. Movement ofannular array 800 in one, two or three-dimensions, or along any path,such as through use of probes and/or any conventional robotic armmechanisms, may be implemented to scan and/or treat a volume or anycorresponding space within a region of interest.

Transducer 404 can also be configured in other annular or non-arrayconfigurations for imaging/therapy functions. For example, withreference to FIGS. 10C-10F, a transducer can comprise an imaging element1012 configured with therapy element(s) 1014. Elements 1012 and 1014 cancomprise a single-transduction element, e.g., a combinedimaging/transducer element, or separate elements, can be electricallyisolated 1022 within the same transduction element or between separateimaging and therapy elements, and/or can comprise standoff 1024 or othermatching layers, or any combination thereof. For example, withparticular reference to FIG. 10F, a transducer can comprise an imagingelement 1012 having a surface 1028 configured for focusing, defocusingor planar energy distribution, with therapy elements 1014 including astepped-configuration lens configured for focusing, defocusing, orplanar energy distribution.

With a better understanding of the various transducer structures, andwith reference again to FIG. 14, how the geometric configuration of thetransducer or transducers that contributes to the wide range oflesioning effects can be better understood. For example, cigar-shapedlesions 1404 and 1406 may be produced from a spherically focused source,and/or planar lesions 1410 from a flat source. Concave planar sourcesand arrays can produce a “V-shaped” or ellipsoidal lesion 1414.Electronic arrays, such as a linear array, can produce defocused,planar, or focused acoustic beams that may be employed to form a widevariety of additional lesion shapes at various depths. An array may beemployed alone or in conjunction with one or more planar or focusedtransducers. Such transducers and arrays in combination produce a verywide range of acoustic fields and their associated benefits. A fixedfocus and/or variable focus lens or lenses may be used to furtherincrease treatment flexibility. A convex-shaped lens, with acousticvelocity less than that of superficial tissue, may be utilized, such asa liquid-filled lens, gel-filled or solid gel lens, rubber or compositelens, with adequate power handling capacity; or a concave-shaped, lowprofile, lens may be utilized and composed of any material or compositewith velocity greater than that of tissue. While the structure oftransducer source and configuration can facilitate a particular shapedlesion as suggested above, such structures are not limited to thoseparticular shapes as the other spatial parameters, as well as thetemporal parameters, can facilitate additional shapes within anytransducer structure and source.

In accordance with various exemplary embodiments of the presentinvention, transducer 404 may be configured to provide one, two and/orthree-dimensional treatment applications for focusing acoustic energy toone or more regions of interest. For example, as discussed above,transducer 404 can be suitably diced to form a one-dimensional array,e.g., transducer 602 comprising a single array of sub-transductionelements.

In accordance with another exemplary embodiment, transducer 404 may besuitably diced in two-dimensions to form a two-dimensional array. Forexample, with reference to FIG. 9, an exemplary two-dimensional array900 can be suitably diced into a plurality of two-dimensional portions902. Two-dimensional portions 902 can be suitably configured to focus onthe treatment region at a certain depth, and thus provide respectiveslices 904 of the treatment region. As a result, the two-dimensionalarray 900 can provide a two-dimensional slicing of the image place of atreatment region, thus providing two-dimensional treatment.

In accordance with another exemplary embodiment, transducer 404 may besuitably configured to provide three-dimensional treatment. For example,to provide-three dimensional treatment of a region of interest, withreference again to FIG. 1, a three-dimensional system can comprise atransducer within probe 104 configured with an adaptive algorithm, suchas, for example, one utilizing three-dimensional graphic software,contained in a control system, such as control system 102. The adaptivealgorithm is suitably configured to receive two-dimensional imaging,temperature and/or treatment or other tissue parameter informationrelating to the region of interest, process the received information,and then provide corresponding three-dimensional imaging, temperatureand/or treatment information.

In accordance with an exemplary embodiment, with reference again to FIG.9, an exemplary three-dimensional system can comprise a two-dimensionalarray 900 configured with an adaptive algorithm to suitably receive 904slices from different image planes of the treatment region, process thereceived information, and then provide volumetric information 906, e.g.,three-dimensional imaging, temperature and/or treatment information.Moreover, after processing the received information with the adaptivealgorithm, the two-dimensional array 900 may suitably providetherapeutic heating to the volumetric region 906 as desired.

In accordance with other exemplary embodiments, rather than utilizing anadaptive algorithm, such as three-dimensional software, to providethree-dimensional imaging and/or temperature information, an exemplarythree-dimensional system can comprise a single transducer 404 configuredwithin a probe arrangement to operate from various rotational and/ortranslational positions relative to a target region.

To further illustrate the various structures for transducer 404, withreference to FIG. 7, ultrasound therapy transducer 700 can be configuredfor a single focus, an array of foci, a locus of foci, a line focus,and/or diffraction patterns. Transducer 700 can also comprise singleelements, multiple elements, annular arrays, one-, two-, orthree-dimensional arrays, broadband transducers, and/or combinationsthereof, with or without lenses, acoustic components, and mechanicaland/or electronic focusing. Transducers configured as sphericallyfocused single elements 702, annular arrays 704, annular arrays withdamped regions 706, line focused single elements 708, 1-D linear arrays710, 1-D curvilinear arrays in concave or convex form, with or withoutelevation focusing, 2-D arrays, and 3-D spatial arrangements oftransducers may be used to perform therapy and/or imaging and acousticmonitoring functions. For any transducer configuration, focusing and/ordefocusing may be in one plane or two planes via mechanical focus 720,convex lens 722, concave lens 724, compound or multiple lenses 726,planar form 728, or stepped form, such as illustrated in FIG. 10F. Anytransducer or combination of transducers may be utilized for treatment.For example, an annular transducer may be used with an outer portiondedicated to therapy and the inner disk dedicated to broadband imagingwherein such imaging transducer and therapy transducer have differentacoustic lenses and design, such as illustrated in FIG. 10C-10F.

Moreover, such transduction elements 700 may comprise apiezoelectrically active material, such as lead zirconante titanate(PZT), or any other piezoelectrically active material, such as apiezoelectric ceramic, crystal, plastic, and/or composite materials, aswell as lithium niobate, lead titanate, barium titanate, and/or leadmetaniobate. Transduction elements 700 may also comprise one or morematching layers configured along with the piezoelectrically activematerial. In addition to or instead of piezoelectrically activematerial, transduction elements 700 can comprise any other materialsconfigured for generating radiation and/or acoustical energy. A means oftransferring energy to and from the transducer to the region of interestis provided.

In accordance with another exemplary embodiment, with reference to FIG.12, an exemplary treatment system 200 can be configured with and/orcombined with various auxiliary systems to provide additional functions.For example, an exemplary treatment system 1200 for treating a region ofinterest 1206 can comprise a control system 1202, a probe 1204, and adisplay 1208. Treatment system 1200 further comprises an auxiliaryimaging modality 1274 and/or auxiliary monitoring modality 1272 may bebased upon at least one of photography and other visual optical methods,magnetic resonance imaging (MRI), computed tomography (CT), opticalcoherence tomography (OCT), electromagnetic, microwave, or radiofrequency (RF) methods, positron emission tomography (PET), infrared,ultrasound, acoustic, or any other suitable method of visualization,localization, or monitoring of SMAS layers within region-of-interest1206, including imaging/monitoring enhancements. Such imaging/monitoringenhancement for ultrasound imaging via probe 1204 and control system1202 could comprise M-mode, persistence, filtering, color, Doppler, andharmonic imaging among others; furthermore an ultrasound treatmentsystem 1270, as a primary source of treatment, may be combined with asecondary source of treatment 1276, including radio frequency (RF),intense pulsed light (IPL), laser, infrared laser, microwave, or anyother suitable energy source.

In accordance with another exemplary embodiment, with reference to FIG.13, treatment composed of imaging, monitoring, and/or therapy to aregion of interest may be further aided, augmented, and/or deliveredwith passive or active devices 1304 within the oral cavity. For example,if passive or active device 1304 is a second transducer or acousticreflector acoustically coupled to the cheek lining it is possible toobtain through transmission, tomographic, or round-trip acoustic waveswhich are useful for treatment monitoring, such as in measuring acousticspeed of sound and attenuation, which are temperature dependent;furthermore such a transducer could be used to treat and/or image. Inaddition an active, passive, or active/passive object 1304 may be usedto flatten the skin, and/or may be used as an imaging grid, marker, orbeacon, to aid determination of position. A passive or active device1304 may also be used to aid cooling or temperature control. Natural airin the oral cavity may also be used as passive device 1304 whereby itmay be utilized to as an acoustic reflector to aid thickness measurementand monitoring function.

During operation of an exemplary treatment system, a lesionconfiguration of a selected size, shape, orientation is determined.Based on that lesion configuration, one or more spatial parameters areselected, along with suitable temporal parameters, the combination ofwhich yields the desired conformal lesion. Operation of the transducercan then be initiated to provide the conformal lesion or lesions. Openand/or closed-loop feedback systems can also be implemented to monitorthe spatial and/or temporal characteristics, and/or other tissueparameter monitoring, to further control the conformal lesions.

With reference to FIG. 13, a collection of simulation results,illustrating thermal lesion growth over time are illustrated. Suchlesion growth was generated with a spherically focused, cylindricallyfocused, and planar (unfocused) source at a nominal source acousticpower level, W0 and twice that level, 2 W0, but any configurations oftransducer can be utilized as disclosed herein. The thermal contoursindicate where the tissue reached 65 □C for different times. The contourfor the cylindrically focused source is along the short axis, orso-called elevation plane. The figure highlights the different shapes oflesions possible with different power levels and source geometries. Inaddition, with reference to FIG. 14, a pair of lesioning and simulationresults is illustrated, showing chemically stained porcine tissuephotomicrographs adjacent to their simulation results. In addition, withreference to FIG. 15, another pair of lesioning results is illustrated,showing chemically stained porcine tissue photomicrographs, highlightinga tadpole shaped lesion and a wedge shaped lesion.

In summary, adjustment of the acoustic field spatial distribution viatransducer type and distribution, such as size, element configuration,electronic or mechanical lenses, acoustic coupling and/or cooling,combined with adjustment of the temporal acoustic field, such as throughcontrol of transmit power level and timing, transmit frequency and/ordrive waveform can facilitate the achieving of controlled thermallesions of variable size, shape, and depths. Moreover, the restorativebiological responses of the human body can further cause the desiredeffects to the superficial human tissue.

The present invention has been described above with reference to variousexemplary embodiments. However, those skilled in the art will recognizethat changes and modifications may be made to the exemplary embodimentswithout departing from the scope of the present invention. For example,the various operational steps, as well as the components for carryingout the operational steps, may be implemented in alternate waysdepending upon the particular application or in consideration of anynumber of cost functions associated with the operation of the system,e.g., various of the steps may be deleted, modified, or combined withother steps. These and other changes or modifications are intended to beincluded within the scope of the present invention, as set forth in thefollowing claims.

What is claimed is:
 1. A method for tightening tissue with an ultrasoundtreatment, the method comprising: providing an ultrasound probecomprising a housing and a piezoelectric therapy transducer for treatinga region of interest, wherein the piezoelectric therapy transducer ishoused within the housing, wherein the region of interest comprises acollagen fiber and a muscular fascia tissue below a skin surface;wherein the collagen fiber is located in any one of the group consistingof: a dermal tissue and an adipose tissue in the region of interest; andtransmitting ultrasound energy from the ultrasound therapy transducerinto the region of interest at a frequency of 4 MHz to 15 MHz, therebyheating the collagen fiber and the muscular fascia tissue in the regionof interest to a temperature in a range of 60° C. to 90° C. to causeshrinkage of the collagen fiber for tightening of the skin surface. 2.The method of claim 1, further comprising providing a piezoelectricultrasound imaging transducer to image the region of interest, whereinthe piezoelectric ultrasound imaging transducer is housed within theultrasound probe.
 3. The method of claim 1, wherein the piezoelectrictherapy transducer comprises a single active ultrasound therapypiezoelectric element with a portion of a spherical surface with a focusat a depth under the skin surface.
 4. The method of claim 1, wherein thepiezoelectric therapy transducer comprises any one or more of the groupconsisting of: a phase focusing, an electronic focusing, an electronicvariable depth, and an electronic dynamically controllable depth underthe skin surface.
 5. The method of claim 1, wherein the collagen fiberis the dermal tissue in the region of interest.
 6. The method of claim1, wherein the ultrasound probe further comprises a storage systemconfigured for stored information, wherein said stored information isselected from the group consisting of one or more of the following:probe identification, calibration, and probe usage history.
 7. Themethod of claim 1, further comprising cooling a region between theultrasound probe and the region of interest, wherein the piezoelectrictherapy transducer comprises an array of piezoelectric therapy elementsconfigured to direct the ultrasound energy into the region of interestat one or more depths within a range of 0.5 mm to 5 mm from the skinsurface tissue.
 8. The method of claim 1, wherein a portion of the probehousing is configured for acoustic coupling to the skin surface.
 9. Themethod of claim 1, further comprising cooling a region between theultrasound probe and the region of interest.
 10. The method of claim 1,wherein the transmitting ultrasound energy from the ultrasoundtransducer into the region of interest is to a depth in a range ofbetween 0.5 mm to 5 mm below the skin surface.
 11. The method of claim1, wherein the transmitting ultrasound energy from the ultrasoundtransducer into the region of interest is to a depth in range of between3 mm to 9 mm below the skin surface.
 12. A method for tightening tissuewith ultrasound energy, the method comprising: providing an ultrasoundimaging transducer for imaging a region of interest under a skinsurface; wherein the region of interest comprises a plurality ofcollagen fibers in a fascia tissue and any one of the group consistingof: a dermal tissue and an adipose tissue in the region of interest;providing a piezoelectric ultrasound therapy transducer for delivering atherapeutic ultrasound energy to the region of interest under the skinsurface to heat the plurality of collagen fibers in the fascia tissueand the any one of the group consisting of: the dermal tissue and theadipose tissue with the therapeutic ultrasound energy at a temperaturein a range of 60° C. to 90° C. to shrink the plurality of collagenfibers in the fascia tissue and the any one of the group consisting of:the dermal tissue and the adipose tissue, thereby tightening the skinsurface; and wherein the imaging transducer and the piezoelectrictherapy transducer are co-housed within a single ultrasound probe. 13.The method of claim 12, wherein the piezoelectric therapy transducer isconfigured to deliver energy at a frequency in a range of 4 MHz to 15MHz.
 14. The method of claim 12, wherein the probe is controlled by acontrol system comprising a microprocessor and a power supply, whereinthe control system is configured to calibrate the ultrasound probe basedon calibration data from a storage system.
 15. The method of claim 14,wherein the ultrasound probe comprising a storage system wherein saidstored information is selected from the group consisting of one or moreof the following: probe identification, calibration, and probe usagehistory.
 16. A method for tightening skin tissue, the method comprising:providing an ultrasound probe comprising a housing and at least onepiezoelectric ultrasound therapy transducer for treating a region ofinterest, wherein the region of interest comprises collagen comprisingany one of the group consisting of: a fascia tissue, a dermal tissue,and an adipose tissue below a skin surface; and wherein thepiezoelectric ultrasound therapy transducer comprises one of the groupconsisting of a spherical focus, a line focus, and a planar focus,wherein ultrasound energy is transmitted from the at least onepiezoelectric ultrasound transducer into the region of interest, therebyheating the collagen in the any one of the group consisting of: thefascia tissue, the dermal tissue, and the adipose tissue in the regionof interest to a temperature in a range of 60° C. to 90° C. to causeshrinkage of the collagen for tightening of the skin surface.
 17. Themethod of claim 16, wherein the piezoelectric ultrasound therapytransducer further comprises one of the group consisting of a phasefocus, an electronic focus, and a mechanical focus.
 18. The method ofclaim 16, wherein the at least one piezoelectric ultrasound therapytransducer is configured to deliver energy at a frequency in a range of4 MHz to 15 MHz, wherein the at least one piezoelectric therapytransducer comprises an array of piezoelectric therapy elementsconfigured to direct ultrasound energy at one or more depths within arange of 0.5 mm to 5 mm below the skin surface tissue.
 19. The method ofclaim 18, further comprising moving the at least one piezoelectricultrasound therapy transducer with a motion mechanism connected to theat least one piezoelectric ultrasound therapy transducer, wherein themotion mechanism comprises an encoder for monitoring a position of theat least one piezoelectric ultrasound therapy transducer on the motionmechanism in the probe housing of the ultrasound probe.
 20. The methodof claim 19, wherein the ultrasound probe comprises a storage systemwith stored information, wherein said stored information is selectedfrom the group consisting of one or more of: a probe identification, acalibration, and a probe usage history.